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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K885216
Device Name ATTACHABLE LANZ (TENTATIVE)
Applicant
Mallinckroot, Inc.
Hook Rd.
Argyle,  NY  12809
Applicant Contact PHILIP E WIEGERT
Correspondent
Mallinckroot, Inc.
Hook Rd.
Argyle,  NY  12809
Correspondent Contact PHILIP E WIEGERT
Regulation Number868.5750
Classification Product Code
BSK  
Date Received12/19/1988
Decision Date 03/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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